“When you select a vendor and agree to a contract, your roles are now somewhat reversed. You were the boss before you handed out the contract, but the minute the contract is done, you lose the leverage you had. How can you maintain more control?” Here are two strategies from biotech and pharma executives.
As concerns about the cost of medicines reach a fever pitch, innovators are looking to leverage a promising advancement to help address the fundamental need for sustainable healthcare in the U.S. — biosimilars.
The clinical trial environment in India has seen a downward trend since 2013, when the government approached the Supreme Court regarding the death of 2,644 volunteers during clinical trials over seven years.
There is a trend within the pharmaceutical, biopharmaceutical, medical device, and vaccine industries to hire more consultants, leading to a staffing ratio that can be up to 50 percent consultants to staff for small to large capital projects.
The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.
Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7. By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises
By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
A discussion on the risks related to bioburden downstream processing and ways to mitigate them. Topics covered include improvements in raw material, equipment design, and chromatography resin properties.
Disposable bioreactors have gained widespread acceptance in cell culture applications because they provide a flexible resource for multiproduct facilities and speed the production of biomolecules.
This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes. For creation of high-density cell banks, Chinese hamster ovary (CHO) cells were expanded using a bioreactor system operated in perfusion mode.
Studies performed on disposable chromatography column housings and disposable flow paths address the concerns of potential leachables from the plastic and elastomeric materials of single-use components.
The most effective way to stop opioid dependence is to eliminate the use of these addictive drugs after surgery altogether. This was the goal of Pacira Pharmaceuticals.
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The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.
One tool holds a unique position among R&D informatics systems -- electronic laboratory notebooks (ELNs). ELNs both produce data and consume information and are particularly powerful.
Vaccine development and manufacture is one of the most challenging tasks within biopharmaceuticals today.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.